Quality Assurance Inspector II - 2nd Shift

Role Summary

Quality Assurance Inspector II – 2nd Shift. Monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested for compliance with established specifications and to ensure quality compliance before, during and after each packaging run.

Responsibilities

• Perform all functions of a QA Inspector I.
• Inspect, sample, and test all incoming raw materials, packaging components, and returned goods according to detailed written procedures.
• Prepare samples for chemical and microbiological analysis (where applicable) and deliver them to the QC lab.
• Inspect and test packaging components using measuring devices to ensure conformance to specifications.
• Maintain detailed records of all sampling, inspection, and testing activities.
• Assign and verify expiry and retest dates for GMP raw materials using COAs.
• Collect packaged product samples for annual stability studies.
• Perform room, equipment, and packaging line checks prior to each manufacturing stage, following written procedures.
• Conduct in-process testing as per manufacturing and packaging batch record instructions.
• Prepare finished product samples for QC lab testing and QA retains, ensuring proper documentation.
• Maintain standard weights for daily balance verification.
• Receive, visually examine, count, preliminarily inspect, and sample labeling components.
• Prepare inspection reports for labeling components/outserts; quarantine and release labels; maintain logs and inventory cards.
• Issue labeling components/outserts per packaging orders and monitor the label room.
• Complete QA final labeled product inspection reports and final line clearance, including labeling and packaging reconciliation paperwork.
• Ensure warehouse compliance regarding isolation of various material statuses.
• Isolate rejected materials generated during batch processing and ensure accountability in batch records.
• Monitor facility and product environmental operating conditions.
• Review engineering records and online batch records for completeness and accuracy prior to next processing step.
• Verify functionality of equipment and controls during batch runs.
• Maintain retention sample room and monitor conditions, update charts, and disposition samples.

Qualifications

Education

• High School or GED - Required

Experience

• 2 years of experience in QA or related field

Skills

• Organizational skills - Advanced
• Creativity and latitude - Advanced
• Basic computer skills (Word and Excel) - Intermediate

Specialized Knowledge

• Proficient in Production Line Clearance procedures
• Strong basic math skills and attention to detail
• Record observations and identify opportunities for process improvement
• Solid understanding of GMP
• Knowledge of SOPs and their application in a regulated environment